Warning letter

Therasage, LLC. [ARCHIVED]: warning letter of Aug 31, 2009

FDA warning letter 54002 · Florida District Office

Key facts

Reference number 54002
Company Therasage, LLC. [ARCHIVED]
Subject Medical Devices/Adulterated/Misbranded
Issue date Aug 31, 2009
Posted date Aug 31, 2009
Issuing office Florida District Office
Product type Devices
CFR sections cited 820, 803, 803.3, 803.17, 807.81, 807.3(d), 807.81(b)
Inspection city San Marcos
Inspection ZIP 78666
Inspection start date Jan 12, 2009
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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